COAs for 21 CFR 111 - Identity, Purity, Strength - Dietary Supplement Industry

Q

qualityqueen1974

#1
Hello fellow cove members,
I am in need of a little help. I work in the dietary supplement industry and we have recently become regulated by the FDA 21 CFR 111. I had an internal audit a few months ago and I am struggling with meeting the auditors requirements for one particular corrective action. We have a process for supplier qualification in place however we do not "confirm" the COA according to our auditor. He mentioned that we must "confirm" identity, purity, strength and composition of all dietary supplement ingredients. This is what we are doing:
1. Every raw material received undergoes identity testing via NIR analysis
2. Every raw material ingredient undergoes microbial analysis to ensure purity
3. Every COA for a raw material is evaluated and reviewed against our product specifications

The COAs typically list results for microbial testing, organoleptic testing, and assays. We do not confirm the assays with an outside laboratory so the auditor says we are not therefore confirming the COA. Is this the only way to confirm the COA?????? am I missing something? any help and guidance would be great.
 
Elsmar Forum Sponsor

Scott Catron

True Artisan
Super Moderator
#2
According to 111.75 (a) (2) (ii) (A), you can accept the results from a supplier's COA if:

You first qualify the supplier by
establishing the reliability of the supplier’s
certificate of analysis through
confirmation of the results of the supplier’s
tests or examinations;


Have you done this?
 
Q

qualityqueen1974

#3
I would say yes and no. let me explain.

Most of our suppliers simply list microbial and organoleptic test results of the COA. we perform this testing in house and I could argue that we validate the COA for those testing requirements through our internal testing methods which are based on AOAC criteria. Have I done an actual review of the supplier in that regard...no. I have not created a report that says that COAs have been validated but I can gather the testing data and put something together. you helped me trigger an idea....thanks. as for the COAs that have assays and other testing that we do not perform, would I have to send all of those out for 3rd party testing to validate the COA on the items that we do not perform?
 

Scott Catron

True Artisan
Super Moderator
#4
as for the COAs that have assays and other testing that we do not perform, would I have to send all of those out for 3rd party testing to validate the COA on the items that we do not perform?
I think to qualify the supplier and use their subsequent COA for acceptance you need to verify their testing in some way. If you can't do it in-house, then you'd have to find someone else.
 
J

jscholen

#5
I'm not in supplements arena, but in medical device, you need to establish, upfront, adequate assurance that your suppliers COA can be trusted.
 
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